Sexual Dysfunction, Physiological
Conditions
Keywords
Sexual Dysfunction, Gynecologic cancer, Cancer survivor, Vaginal dilator
Brief summary
This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™ Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water based lubricant, on sexual dysfunction, compared to the current standard care for women with no evidence of disease after treatment for gynecologic cancers. In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. Those women who report sexual dysfunction will be given the option to enroll in the study. After enrollment, the Female Sexual Function Index (FSFI) and other quality of life surveys will be administered at baseline. The participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (VRP). Throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. They will also be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.
Interventions
DEVICEVaginal Renewal Program
The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
DEVICEVaginal Dilator
Still vaginal dilator with lubricant.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * History of a gynecologic cancer * No evidence of disease at time of inclusion in the study * Postmenopausal (either surgical or natural menopause) * Self report of sexual dysfunction that did not predate cancer diagnosis * Suspected physical component to sexual dysfunction with the participant, not sexual partner * Desire to improve sexual function * ECOG Performance status score of 2 or better * Six months or greater from last surgical and/or radiation treatment
Exclusion criteria
* History of sexual reassignment * Presence of vaginal fistula * Does not desire to improve sexual function * Already using the vaginal renewal program * Not fluent in English * Incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months | At baseline and 6 months | Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Marinoff Scale at 6 Months | At baseline and 6 months | The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale: 0 = no pain with intercourse 1. = pain with intercourse that doesn't prevent the completion 2. = pain with intercourse requiring interruption or discontinuance 3. = pain with intercourse preventing any intercourse Difference in Marinoff scores reported, value at 6 months minus value at baseline. |
| FACT-G Score | At baseline and 6 months | The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported. |
| Vaginal Length | At baseline and 6 months | Change in vaginal length as measured from baseline to 6 months. |
Countries
United States
Participant flow
Recruitment details
Participants with a history of a gynecologic cancer and self-reported sexual dysfunction that was new or worsened since cancer diagnosis, and were randomized to one of two arms. All participants enrolled at the Gynecologic Oncology and Radiation Oncology clinics at the University of Wisconsin Carbone Cancer Center.
Participants by arm
| Arm | Count |
|---|---|
| Vaginal Renewal Program Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant. | 16 |
| Standard of Care This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator: Still vaginal dilator with lubricant. | 13 |
| Total | 29 |
Baseline characteristics
| Characteristic | Total | Vaginal Renewal Program | Standard of Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 15 Participants | 11 Participants |
| Pelvic Radiation No Prior Pelvic Radiation | 26 participants | 14 participants | 12 participants |
| Pelvic Radiation Prior Pelvic Radiation | 3 participants | 2 participants | 1 participants |
| Primary Disease Site Cervix | 4 participants | 3 participants | 1 participants |
| Primary Disease Site Dual Primary (Ovary and Endometrium) | 2 participants | 1 participants | 1 participants |
| Primary Disease Site Endometrium | 12 participants | 6 participants | 6 participants |
| Primary Disease Site Ovary | 10 participants | 5 participants | 5 participants |
| Primary Disease Site Vulva | 1 participants | 1 participants | 0 participants |
| Region of Enrollment United States | 29 participants | 16 participants | 13 participants |
| Sex: Female, Male Female | 29 Participants | 16 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 16 | 3 / 13 |
| serious Total, serious adverse events | 0 / 16 | 0 / 13 |
Outcome results
Primary
Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months
Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.
Time frame: At baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vaginal Renewal Program | Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months | 5.575 Units on a scale |
| Standard of Care | Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months | 6.069 Units on a scale |
p-value: 0.89ANOVA
Secondary
Change in Marinoff Scale at 6 Months
The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale: 0 = no pain with intercourse 1. = pain with intercourse that doesn't prevent the completion 2. = pain with intercourse requiring interruption or discontinuance 3. = pain with intercourse preventing any intercourse Difference in Marinoff scores reported, value at 6 months minus value at baseline.
Time frame: At baseline and 6 months
Population: Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vaginal Renewal Program | Change in Marinoff Scale at 6 Months | -0.857 units on a scale |
| Standard of Care | Change in Marinoff Scale at 6 Months | -0.818 units on a scale |
Secondary
FACT-G Score
The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported.
Time frame: At baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vaginal Renewal Program | FACT-G Score | 4.375 units on a scale |
| Standard of Care | FACT-G Score | 4.872 units on a scale |
Secondary
Vaginal Length
Change in vaginal length as measured from baseline to 6 months.
Time frame: At baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vaginal Renewal Program | Vaginal Length | 1.188 Centimeters |
| Standard of Care | Vaginal Length | 0.154 Centimeters |